Patients with primary hepato-biliary malignancies or liver metastases from gastrointestinal cancer suffer substantial morbidity and mortality from their hepatic disease. Curative resection is feasible only for selected subgroups of patients. The majority of patients have unresectable and incurable disease. Aggressive arterial and systemic chemotherapy have been used in recent years with improved response and survival. However, a significant number of patients, at least one-third of patients with liver metastases from colorectal cancer and two-third or higher of unresectable hepatobiliary cancer, continue to die of liver failure from progressive disease in the liver. Percutaneous ethanol injections, chemoembolization, cryotherapy and thermal ablation using radiofrequency have been used to treat selected patients with smaller tumors (3-4 cm) in areas away from major blood vessels and the biliary tract. However, most unresectable liver cancers did not fit the criteria for these treatments. Therefore, other regional therapeutic option like external radiation therapy may be considered for local control in the liver or symptom palliation

Eligible patient will be treated with 48 Gy in 4 fractions encompassing the entire target lesion in 2 weeks with a minimum of 48 hours between each dose.

Radiation: Stereotactic Body Radiation Therapy

Radiation Dose: 48 Gy in 4 fractions in 2 weeks. A minimum of 48 hours should separate each treatment (e.g. every Tuesday and Friday). The dose is prescribed to the marginal isodose (80-90%) that encompasses the entire target lesion (GTV). Treatment will be delivered using a linear accelerator. For verification of the accuracy of these external skin fiducial markers, 10 patients will also have implanted internal gold coil markers. The implantable gold coil markers will be implanted into the liver in the proximity of the target lesions via a percutaneous transhepatic route under fluoroscopy guidance.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Histologically conformation of liver malignancy

Solitary or multiple liver tumors amenable to SBRT

No jaundice or liver dysfunction

For metastases, the primary tumor site has been adequately treated.

For primary hepatoma, no extra-hepatic disease

Karnofsky > 70

Exclusion Criteria:

no extra-hepatic disease

Liver failure or inadequate liver function

Ascites

Previous radiation therapy to the liver

lesions invading major blood vessels in the porta region

Contraindication to receive radiation therapy in the liver

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691691